This invention generally relates to a packaging system for flexible elongated articles and particularly for sterilized elongated articles such as dilatation catheters and guidewires for percutaneous transluminal coronary angioplasty (PTCA).
In PTCA procedures, a guiding catheter having a preshaped distal tip is percutaneously introduced into the cardiovascular system of a patient and advanced therein until the preshaped distal tip thereof is disposed within the aorta adjacent the ostium of the desired coronary artery. The guiding catheter is twisted or torqued from the proximal end to turn the distal tip of the guiding catheter so that it can be guided into the thereof is introduced into and advanced through the guiding catheter to the distal tip thereof and then out of the distal tip of the guiding catheter until the balloon on the distal extremity of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the flexible, relatively inelastic balloon is inflated to a predetermined size with radiopaque liquid at relatively high pressures (e.g., 4-12 atmospheres) to dilate the stenosed region of the diseased artery. The balloon is then deflated so that the dilatation catheter can be removed from the dilated stenosis and blood flow can then be resumed therethrough. With over-the-wire and rapid exchange type dilatation catheters, they are advanced out of the guiding catheter over a previously positioned guidewire to the desired location within the patient's coronary anatomy. With fixed wire catheters the guiding member is fixed within the catheter so both are advanced together out the distal end of the guiding catheter to the desired location within the coronary arteries of the patient.
Before a balloon dilatation catheter is inserted into the patient, liquid, such as the radiopaque liquid used for inflating the balloon, is injected into the catheter in order to vent entrapped air from the interior of the catheter. The entrapped air may be vented through a venting tube such as described in U.S. Pat. No. 4,323,071 (Simpson et al.) or through a venting passageway such as described in U.S. Pat. No. 4,692,200 (Powell) and U.S. Pat. No. 4,821,22 (Miller et al.) which are incorporated herein by reference. For the venting to be successful, the catheter must usually be manipulated to guide the bubbles of entrapped air within the catheter into a position adjacent to the venting means to allow the entrapped air to pass through the venting means. While the catheter is being manipulated during the venting procedure, care must be exercised to ensure that the sterility of the catheter is not compromised by the catheter contacting a non-sterile surface. Even after the catheter has been vented, the catheter, which is over three feet long, must be placed in a sterile environment until it is used in the angioplasty procedure. This typically involves laying the catheter over the draped surgical site on the patient. However, while the draped surgical site is sterile, it is not uncommon for the vented dilatation catheter to come into contact with a non-sterile surface, requiring discarding the vented catheter and prepping another dilatation catheter for the angioplasty. This replacement is expensive and inconvenient for the physician because then the replacement catheter itself must be vented to remove entrapped air.
What has been needed and heretofore unavailable is a packaging system which allows the catheter or other elongated device to be prepped and stored in a sterile environment with little risk of contact with a non-sterile surface prior to use. The present invention satisfies this and other needs.